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A Phase III Study to Test the Benefit of a New Kind of Anti-cancer Treatment in Patients With Melanoma, After Surgical Removal of Their Tumor

This study has been terminated.
(The study was terminated early following assessment of the two co-primary endpoints showing the lack of efficacy of the study product.)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00796445
First received: November 21, 2008
Last updated: September 29, 2016
Last verified: September 2016

November 21, 2008
September 29, 2016
December 2008
September 2015   (final data collection date for primary outcome measure)
Disease Free Survival (DFS) [ Time Frame: At Final analysis (23 May 2013) and at follow-up analysis (18 Aug 2015) ] [ Designated as safety issue: No ]

DFS was defined as the time from randomization to either the date of first recurrence of the disease (date as assessed by the investigator) or the date of death (whatever the cause), whichever occurred first.

Notes: -Types of recurrence to be considered as an event included loco-regional and distant metastases. -In addition, any death occurring without prior documentation of tumor recurrence was considered as an event (and was not censored in the statistical analysis) as this approach was less prone to introduce bias. -If no event occurred by the time of the analysis, then the time to event was censored at the date of the last assessment (tumor assessment/visit) of the patient in question. -Any new primary cancer at another site, including second primary melanoma, was not considered as a recurrence and had to be reported as a Serious Adverse Event (SAE).

Disease Free Survival [ Time Frame: Once the pre-defined number of events is reached ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00796445 on ClinicalTrials.gov Archive Site
  • Overall Survival (OS) [ Time Frame: At final analysis (23 May 2013) and Follow-up analysis (18 Aug 2015) ] [ Designated as safety issue: No ]
    Overall Survival (OS) was defined as the interval from randomization to the date of death, irrespective of the cause of death; Patients alive at the time of the analysis were censored on the date last known to be alive.
  • Disease-free specific survival (DFSS) [ Time Frame: At Final analysis (23 May 2013) ] [ Designated as safety issue: No ]
    Disease Free Specific Survival (DFSS) was defined as the interval from randomization to the date of first recurrence of disease or date of death due to melanoma (cause as assessed by investigator), whichever occurred first. Patients who died due to a cause other than the disease under study and patients alive at the time of analysis were censored on the date of last assessment (visit or tumor assessment).
  • Distant metastasis-free survival (DMFS) [ Time Frame: At Final analysis (23 May 2013) ] [ Designated as safety issue: No ]
    Distant Metastasis Free Survival (DMFS) was defined as the interval from randomization to the date of first distant metastasis or date of death, whichever occurred first. Patients alive and without distant metastases were censored at the date of last assessment (visit or tumor assessment, or date of last tumor assessment as documented during the yearly contact follow-up period).
  • Health-related quality of life [ Time Frame: At various protocol-defined timepoints: Week 0, 6, 12, on and the day after the day of treatment administration (TA), at Month 6, 9, 12, 24, at the Concluding visit + 6 months and +12 Months and at disease recurrence ] [ Designated as safety issue: No ]
    The assessment of health-related quality of life was restricted to patients who consented to study participation after Protocol Amendment 1 became effective at their study site, and for whom a validated version of the EQ-5D questionnaire was available in their native language.
  • Number of subjects with Anti-MAGE-A3 antibody concentrations above the cut-off values [ Time Frame: After 2, 4, 6, 7 and 9 administrations, post-treatment (i.e., at concluding visit) and one year after concluding visit (i.e., at follow-up visit 2) ] [ Designated as safety issue: No ]
    The cut-off value was 27 ELISA units per millilitre (EL.U/mL).
  • Anti-MAGE-A3 antibody geometric mean concentration [ Time Frame: After 2, 4, 6, 7 and 9 administrations, post-treatment (i.e., at concluding visit) and one year after concluding visit (i.e., at follow-up visit 2) ] [ Designated as safety issue: No ]
    Geometric mean concentration (GMC) was expressed as ELISA units per millilitre (EL.U/mL).
  • Number of subjects with Anti-MAGE-A3 antibody response [ Time Frame: After 2, 4, 6, 7 and 9 administrations, post-treatment (i.e., at concluding visit) and one year after concluding visit (i.e., at follow-up visit 2) ] [ Designated as safety issue: No ]

    Treatment response defined as:

    • For initially seronegative patients: post-vaccination antibody concentration ≥ 27 EL.U/mL;
    • For initially seropositive patients: post-vaccination antibody concentration ≥ 2 fold the pre-vaccination antibody concentration.
  • Number of subjects with any adverse events (AEs) [ Time Frame: Up to 30 days after each study dose ] [ Designated as safety issue: No ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
  • Number of subjects with any serious adverse events (SAEs) [ Time Frame: Up to 30 days after the last administration of study treatment ] [ Designated as safety issue: No ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
  • Number of subjects with potential immune-mediated diseases (pIMDs) [ Time Frame: Up to 30 days after the last administration of study treatment ] [ Designated as safety issue: No ]
    Mediated Disorders (pIMDs) were to be collected up to 5 years after first treatment administration or study withdrawal.
  • Overall Survival [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
  • Disease-free specific survival [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
  • Distant metastasis-free survival [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
  • Anti-MAGE-A3 and anti-protein D seropositivity status. [ Time Frame: Post-treatment and 1 year after concluding visit. ] [ Designated as safety issue: No ]
  • Occurrence of adverse events including abnormal haematological and biochemical parameters. [ Time Frame: Up to 30 days after each study dose. ] [ Designated as safety issue: Yes ]
  • Occurrence of serious adverse events and autoimmunity events. [ Time Frame: During the whole study duration up to 30 days after the last administration of study treatment. ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Phase III Study to Test the Benefit of a New Kind of Anti-cancer Treatment in Patients With Melanoma, After Surgical Removal of Their Tumor
GSK 2132231A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resected Melanoma

The purpose of this clinical trial is to evaluate the benefit of the immunotherapeutic product GSK 2132231A in preventing disease relapse when given to melanoma patients, after surgical removal of their tumor.

This Protocol Posting has been updated following Amendments 1 of the Protocol, March 2010. The impacted sections are outcome measures and entry criteria.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Melanoma
  • Drug: GSK 2132231A
    IM solution, a course of 13 injections will be administered over 27 months
  • Drug: Placebo
    IM solution, a course of 13 injections will be administered over 27 months
  • Experimental: MAGE-A3 Group
    Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI.
    Intervention: Drug: GSK 2132231A
  • Placebo Comparator: Placebo Group
    Patients who received up to 13 doses of placebo.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1351
January 2016
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent signed.
  • Male or female patient with histologically proven stage IIIB or IIIC cutaneous melanoma presenting with macroscopic lymph node involvement suitable for surgery.
  • The patient must have been surgically rendered free of disease before the randomization.
  • Patient is ≥ 18 years old at the time of signing the informed consent form.
  • The patient's lymph node tumor shows expression of the MAGE-A3 gene.
  • The patient has fully recovered from surgery.
  • ECOG performance status of 0 or 1 at the time of randomization.
  • The patient must have adequate organ functions as assessed by standard laboratory criteria.
  • If the patient is female, she must be of non-childbearing potential, or practice adequate contraception.
  • In the opinion of the investigator, the patient can and will comply with all the requirements of the protocol.

Exclusion Criteria:

  • The patient suffers from a mucosal or ocular melanoma.
  • The patient has or has had any history of in-transit metastases
  • The patient has been treated or is scheduled to be treated with an adjuvant anticancer therapy after the surgery that qualifies the patient for inclusion in the present trial.
  • The patient requires concomitant chronic treatment with systemic corticosteroids or any other immunosuppressive agents.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study treatment.
  • The patient has a history of autoimmune disease.
  • The patient has a family history of congenital or hereditary immunodeficiency.
  • The patient is known to be positive for Human Immunodeficiency Virus (HIV) or has another confirmed or suspected immunosuppressive or immunodeficient condition.
  • History of allergic disease or reactions likely to be exacerbated by any component of the treatments.
  • The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.
  • The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
  • The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
  • The patient has an uncontrolled bleeding disorder.
  • For female patients: the patient is pregnant or lactating.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Czech Republic,   Estonia,   France,   Germany,   Greece,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   New Zealand,   Norway,   Poland,   Romania,   Russian Federation,   Serbia,   Spain,   Sweden,   Switzerland,   Taiwan,   Ukraine,   United Kingdom
 
NCT00796445
111482
Not Provided
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP